Speaking of Relistor, the FDA AdCom meeting for mu-opioid antagonists was originally scheduled to take place this week. A few weeks ago, SLXP said a possible time for the meeting might be late May, but no firm dates announced yet. Still waiting.
Do a google search for "Behind The Scenes With Dream Team, CytRx And Galena".
Article by Richard Pearson discusses how GALE and CYTR paid Dream Team (aka MissionIR) to promote the stocks. The MO is to release a large number of hyping articles on Seeking Alpha, Motley Fool, Wall St. Cheat Sheet and even Forbes. Articles were coordinated with company secondaries and executive sales of stock. Stringers are paid to write articles for publication, submitted to CYTR and GALE management for editing, then released for publication. Evidence includes draft articles with company edits, conclusively documented because the Microsoft Word track changes feature was turned on! Author identities and bios were fabricated. No disclosures anywhere. There are probably other biotechs involved. As you might guess, there are numerous potential violations of securities laws.
Purdue Pill May Force Zogenix’s Rival Drug Off Market
By Drew Armstrong Mar 12, 2014 12:01 AM ET
Purdue Pharma LP plans to apply for regulatory approval of a tamper-resistant competitor to Zogenix Inc. (ZGNX)’s powerful pain pill, a move that could get its rival’s drug pulled from the market by U.S. regulators.
Purdue’s experimental drug hydrocodone bitartrate met the goal of reducing chronic low-back pain in a final-stage trial, the closely held company said today in a statement. Purdue’s pill is hard to crush and snort or inject, while Zogenix’s Zohydro ER doesn’t have abuse-deterrent features.
Zohydro’s potential for abuse led two U.S. senators this month to ask the Food and Drug Administration to pull the medicine from the market. The concern that the pill could be crushed and snorted was strong enough that when the drug was approved the U.S. regulator said its time on the market could be limited.
“If and when they, or another manufacturer, are able to create an abuse-deterrent formulation that remains safe and effective for patients, we would certainly give serious consideration to assuring that any non-abuse formulations are removed from the market,” Bob Rappaport, the FDA’s director of pain drugs, said in an Oct. 25 review of Zohydro’s approval.
Purdue plans to ask the FDA for a priority review that would cut two to three months off the 10 months the agency sets as a goal to examine applications, according to the company.
Funny how the day traders come and go. On March 4 when NKTR rocketed higher, I counted over 20 tweets about NKTR by 10 AM. Today there are only two tweets so far, and they are both from spam sites. Looks like the momo players have moved to greener pastures for now.
If you think the coal guy and pennystock were obnoxious, well... This board has become infested with parrot spam. Not only do they post messages that promote spam sites, they also reply to existing threads with messages that are exact copies of words others have posted. Yahoo has been good about removing standard spam after a while, but since these parrot messages aren't spam in the strictest sense, Yahoo doesn't yet do anything about it. The RDI message board has become completely unusable due to these clowns. It's already a problem here, and it's probably going to get worse.
They own a Pennysaver newspaper where I live. It is delivered free, and is pure advertisements. They recently added a few syndicated comics and puzzles, which should provide incentive for people to look at some of the pages. I think they believe that increased advertising revenue will pay for the content.
Dr. Davis is a good guy and an asset to the company. He was voted off the board because no one knew about him prior to last year's stockholder meeting. At the meeting (and after the vote), he showed great knowledge of the company and its markets. I think if people had known about more about him before the vote, the result would have been different.
There is a large community of day traders who like to trade the hottest stocks. The term "momo players" is used to describe them, because they buy stocks with "momentum". You see brokerage ads on CNBC promoting "trading platforms", geared for this crowd. They like to communicate and promote to help each other out, one way is through Twitter. I just looked at Twitter, here are a few recent messages.
Tom Minnich @thomas_minnich · 15m
@AjTrader7 fyi... $NKTR & $BIOD are break-out. I like these longs today.
StockAddict @abuabdulmujeeb · 16m
$NKTR running as told :)
Nikki Dunn @FitTraderChick · 16m
I should have listened to @ChrisDunnTV .. closed $NKTR too early lol ..sorry honey
Last year I actually did look up Smith, he was still actively posting on other boards, but now I don't remember which ones.
Good luck to you!
Biotech is white hot these days, especially among momo players. NKTR was mentioned often in the Twittersphere this morning prior to the open as a stock with strong momentum. Enjoy the ride!
They hired an experienced hand to manage the Australian and New Zealand properties. Hopefully he can extract additional value.
William P. Forbes - Chief Development Officer and Executive Vice President of Research & Development
Right. And let me see if I can handle the RELISTOR questions. I'm a little hesitant to say anything about RELISTOR dates given the fact that they've already had. Because of the scheduling conflicts cancel the last one that was going be coming up here in March. But it looks like now it may be near the end of May, is one of the new date -- or 2 days will be. But I think right now, it's a little early, until everybody has a chance to weigh in if those dates are acceptable. But I think it's -- you can look possibly towards the end of May at this point in time.
By way of comparison, here were the BIIB Phase III topline results.
In the A-LONG study, 165 male patients aged 12 years and older were enrolled. The A-LONG study had three treatment arms: individualized prophylaxis, weekly prophylaxis and episodic (on-demand) treatment (Arms 1, 2 and 3, respectively). In a subgroup of patients across treatment arms, rFVIIIFc was evaluated in the perioperative management of patients who required a major surgical procedure during the study.
Overall, 93 percent of patients completed the study. Recombinant FVIIIFc was generally well-tolerated. No inhibitors to rFVIIIFc were detected and no cases of anaphylaxis were reported in any patients, all of whom switched from commercially-available Factor VIII products. No serious adverse events were assessed to be related to drug by the investigator. The most common adverse events (incidence of ≥5 percent) occurring outside of the perioperative management period were nasopharyngitis, arthralgia, headache and upper respiratory tract infection.
The median annualized bleeding rates (ABR), including spontaneous and traumatic bleeds, were 1.6 in the individualized prophylaxis arm, 3.6 in the weekly prophylaxis arm and 33.6 in the episodic treatment arm. In the individualized prophylaxis arm, the median dosing interval was 3.5 days. During the last three months on study, 30 percent of patients in the individualized prophylaxis arm achieved a mean dosing interval of five days.
BAX-855 will compete against Bayer and BIIB products.
134 subjects were treated in the study. Subjects selected either on-demand or prophylactic treatment upon enrollment. All subjects in the three prophylaxis arms began treatment with the site-specific PEGylated recombinant human factor VIII twice per week. After a ten-week period subjects experiencing more than one bleed during this assessment period stayed on two infusions per week at a higher dose and all other subjects were randomized to either every five- or seven-day treatment for six months. After randomization, subjects who assessed their bleeding control as not adequate could leave the assigned treatment regimen and increase their infusion frequency.
88 percent of subjects met the pre-defined criterion of bleeding control in the ten-week initial assessment period and qualified for randomization. All subjects receiving infusion every five days (n=43) remained in this treatment arm. 44 percent of subjects in the every-five-day treatment arm experienced no bleeds. A median annualized bleeding rate (ABR) of 1.9 was observed in this treatment arm. 74 percent of the subjects receiving infusion every seven days (n=43) remained in their treatment arm. 37 percent experienced no bleeds. A median ABR of 3.9 (including non-completers) was observed in this treatment arm. The 13 subjects who remained in the two times per week treatment arm, because of their high bleeding rate during the assessment period, reduced their median ABR from 17.4 to 4.1 following dose increase. By comparison, subjects who were treated on-demand (n=20) had a median ABR of 23.
Detailed data are scheduled for presentation at the World Federation of Hemophilia Meeting in May 2014 in Melbourne, Australia.
According to a letter I received from IR in 2012, there is no milestone payment for Levadex approval. Royalties are likely in the 3-5% range like other contracts from that period.